Recognized standard
F3090-20
FDA recognition 11-382 · ASTM · Orthopedic
Key facts
| Recognition number | 11-382 |
|---|---|
| Designation | F3090-20 |
| Title | Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This test method is intended to evaluate the fatigue strength of metallic acetabular shells with hemispheric outer surfaces. 1.2 This test method, as described, is not intended to evaluate the following: the strength of components that may be mated with the acetabular shells (for example… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: